ARCHITECT HBsAg Next Qualitative/ Next Confirmatory

FDA Premarket Approval P210003 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceARCHITECT HBsAg Next Qualitative/ Next Confirmatory
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-09
Decision Date2022-09-30
PMAP210003
SupplementS001
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Laboratories
100 Abbott Park Road
dept: 09aa Bldg: Ap8-1
abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change In Test Method Used In The Manufacture Of An Assay Component

Supplemental Filings

Supplement NumberDateSupplement Type
P210003Original Filing
S005 2023-01-06 30-day Notice
S004
S003 2022-11-07 30-day Notice
S002 2022-09-14 30-day Notice
S001 2022-09-09 30-day Notice

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